| CTRI Number |
CTRI/2024/02/062856 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
13/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Measurement of pressure inside eye after surgery |
|
Scientific Title of Study
|
Prevalence of raised intraocular pressure in post cataract surgery following topical steroid usage-a cross sectional study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arun kumar |
| Designation |
Junior resident |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Rohilkhand medical college and hospital, pilibhit bypass road, bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
7030327736 |
| Fax |
|
| Email |
arunbhadana05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Jain |
| Designation |
PROFESSOR |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Ophthalmology, Rohilkhand medical college and hospital , pilibhit bypass road, bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9479641462 |
| Fax |
|
| Email |
ritujain2769@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Jain |
| Designation |
PROFESSOR |
| Affiliation |
Rohilkhand medical college and hospital |
| Address |
Department of Ophthalmology, Rohilkhand medical college and hospital , pilibhit bypass road, bareilly.
Bareilly
UTTAR PRADESH
243006
India |
| Phone |
9479641462 |
| Fax |
|
| Email |
ritujain2769@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rohilkhand medical college and hospital, pilibhit bypass road, bareilly |
|
|
Primary Sponsor
|
| Name |
ARUN KUMAR |
| Address |
Rohilkhand medical college and hospital , pilibhit bypass road, bareilly. |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| arun kumar |
Department of ophthalmology |
Department of ophthalmology, Rohilkhand medical college and hospital pilibhit bypass road, bareilly
Bareilly
UTTAR PRADESH |
7030327736
arunbhadana05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RMCH, Bareilly. U.P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients having senile cataracts who underwent cataract surgery and received topical steroid post-operatively.
Patients with central corneal thickness 520µ to 550µ.
Patients giving an informed consent for the study.
|
|
| ExclusionCriteria |
| Details |
Cataract due to metabolic disorders, and traumatic cataract
Cataract surgery with introaperative complications
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the prevalence of increase in intraocular pressure after the use of topical steroid in post operative period in patients undergoing uncomplicated cataract surgery. |
DAY 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find any changes in intraoccular pressure after cataract surgery |
After surgery |
|
|
Target Sample Size
|
Total Sample Size="169"
Sample Size from India="169"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
After taking approval from the institutional ethics
committee (IEC), this study will be conducted
by recruiting the patients coming to eye OPD and fulfilling the
inclusion criteria, after obtaining informed and written consent .
A detailed history will be taken, so as to
exclude other causes of cataract. Any significant medical or surgical history
will be taken and thorough ophthalmologic examination will be done, including
Vision assessment by LogMAR chart, Slit lamp biomicroscopy to assess anterior
segment.
Ophthalmoscopy and B-scan ultrasound to assess
posterior segment of eyeball, Keratometry and Biometry, Gonioscopy to exclude occludable/closed angle of angle
of anterior chamber. Central Corneal Thickness (CCT) will be assessed by
ultrasonic pachymetry to exclude patients with thin and thick corneas. IOP
assessment with Non contact Tonometry (NCT) will be carried out.
Patients
will undergo cataract surgery under local anaesthesia (peribulbar block).
Occurrence of any major intraocular complication will exclude the patient from
the study.
,
patients will receive topical e/d
prednisolone. Dosages will be tapered subsequently in 4 to 6 weeks. |